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The Safety and Effectiveness of Zidovudine in the Treatment of Patients with Early AIDS Related Complex Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on The Safety and Effectiveness of Zidovudine in the Treatment of Patients with Early AIDS Related Complex conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. The Safety and Effectiveness of Zidovudine in the Treatment of Patients with Early AIDS Related Complex Clinical research trials and The Safety and Effectiveness of Zidovudine in the Treatment of Patients with Early AIDS Related Complex healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like The Safety and Effectiveness of Zidovudine in the Treatment of Patients with Early AIDS Related Complex. The Safety and Effectiveness of Zidovudine in the Treatment of Patients with Early AIDS Related Complex Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a The Safety and Effectiveness of Zidovudine in the Treatment of Patients with Early AIDS Related Complex clinical trial. Human subjects often obtain the finest healthcare possible for their The Safety and Effectiveness of Zidovudine in the Treatment of Patients with Early AIDS Related Complex condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
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Home > "T" Clinical Trials Conditions > The Safety and Effectiveness of Zidovudine in the Treatment of Patients with Early AIDS Related Complex  The Safety and Effectiveness of Zidovudine in the Treatment of Patients with Early AIDS Related Complex
The Safety and Effectiveness of Zidovudine in the Treatment of Patients with Early AIDS Related Complex
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: To determine the safety and usefulness of zidovudine (AZT) for the treatment of patients with early symptomatic HIV infection or early AIDS related complex (ARC). The ability of AZT to suppress HIV, to improve body defenses, and to prevent the occurrence or development of AIDS or advanced ARC is being evaluated. In one human study, patients with AIDS or advanced ARC who received AZT had fewer life-threatening infections, improved in weight and performance, and lived longer than patients who received a placebo (inactive medication). Further studies are needed because toxic effects associated with the use of AZT were noted and the long-term effectiveness and toxicity of AZT are still unknown. It is also unknown if AZT will benefit patients with less severe HIV infections such as early ARC or PGL.
Details: In one human study, patients with AIDS or advanced ARC who received AZT had fewer life-threatening infections, improved in weight and performance, and lived longer than patients who received a placebo (inactive medication). Further studies are needed because toxic effects associated with the use of AZT were noted and the long-term effectiveness and toxicity of AZT are still unknown. It is also unknown if AZT will benefit patients with less severe HIV infections such as early ARC or PGL. Patients accepted into the study are randomly assigned to receive either AZT or placebo. Treatment continues for a minimum of 104 weeks beyond the time the last patient enters the study. If the study medication causes toxic effects, the dose is decreased or temporarily stopped, and if the toxic effects are severe, then the medication will be stopped permanently. Participants visit the clinic every 2 weeks during the first 16 weeks and once a month thereafter. Throughout the study frequent blood samples are taken to monitor the effectiveness and safety of the treatment. AMENDED: The placebo arm has been discontinued as of August 3, 1989 and the AZT dose has been reduced.
Eligibility:
Study Type: Interventional, Treatment, Parallel Assignment
Minimum Age/Maximum Age: 12 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria - Patients must have a positive antibody to HIV confirmed by a federally licensed ELISA test kit. - The CD4 cell count must be 201 - 799 cells/mm3 measured on two separate occasions within 60 days at least 72 hours apart prior to study entry (at least 1 of 2 counts and the mean must be < 800 cells/mm3, and at least 1 of 2 counts and the mean must be > 200 cells/mm3). The last count must be within 14 days of study entry. Concurrent Medication: Allowed: - Acetaminophen and acetaminophen products but use should be minimized. Continuous use for > 72 hours is discouraged. - Aerosolized pentamidine. Prior Medication: Allowed: - Chemoprophylaxis for Pneumocystis carinii pneumonia with aerosolized pentamidine of 300 mg every 4 weeks through the Respirgard II nebulizer if patient has CD4(+) count < 200 cells/mm3 measured on 2 determinations at least 48 hours apart. Exclusion Criteria Concurrent Medication: Excluded: - Other antiretroviral agents, biologic modifiers or corticosteroids. - Other experimental medications. - Systemic chemoprophylaxis of Pneumocystic carinii pneumonia (PCP) - aerosolized pentamidine is allowed. Prior Medication: Excluded: - Zidovudine (AZT). - Other antiretroviral agents. - Excluded within 30 days of study entry: - Biologic modifiers or corticosteroids. - Excluded within 60 days of study entry: - Ribavirin. Prior Treatment: Excluded within 30 days of study entry: - Blood transfusions. Patients may not have any of the following diseases or symptoms: - Active oral candidiasis at entry. - An opportunistic infection or malignancy fulfilling the definition of AIDS (CDC Surveillance Case Definition for Acquired Immunodeficiency Syndrome). - Temperature > 38.5 degrees C persisting for > 14 consecutive days or > 15 days in a 30-day interval present at entry. - Chronic diarrhea defined as = or > 3 liquid stools per day, persisting for > 14 days without a definable cause during the past 2 years. - HIV neurologic disease as manifested by motor abnormalities including impaired rapid eye movements or ataxia; motor weakness in the lower extremities; sensory deficit consistent with a peripheral neuropathy; bladder or bowel incontinence. - Concurrent neoplasms other than basal cell carcinoma of the skin or in situ carcinoma of the cervix. - Subjects with hemophilia should be evaluated and treated under the hemophilia protocols, if available at that ACTG. Patients may not have any of the following diseases or symptoms: - Active oral candidiasis at entry. - An opportunistic infection or malignancy fulfilling the definition of AIDS (CDC Surveillance Case Definition for Acquired Immunodeficiency Syndrome). - Temperature > 38.5 degrees C persisting for > 14 consecutive days or > 15 days in a 30-day interval present at entry. - Chronic diarrhea defined as = or > 3 liquid stools per day, persisting for > 14 days without a definable cause during the past 2 years. - HIV neurologic disease as manifested by motor abnormalities including impaired rapid eye movements or ataxia; motor weakness in the lower extremities; sensory deficit consistent with a peripheral neuropathy; bladder or bowel incontinence. - Concurrent neoplasms other than basal cell carcinoma of the skin or in situ carcinoma of the cervix. - Subjects with hemophilia should be evaluated and treated under the hemophilia protocols, if available at that ACTG. Active drug or alcohol abuse.
Total Enrollment: 538
Location and Contact Information:
Overall Study Official:
MAFischl, Study Chair,
Univ of Miami School of Medicine
Miami, Florida, 331361013
United States
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325
United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287
United States
Bronx Veterans Administration / Mount Sinai Hosp
Bronx, New York, 10468
United States
SUNY / State Univ of New York
Syracuse, New York, 13210
United States
Univ of Washington
Seattle, Washington, 98105
United States
Harbor UCLA Med Ctr
Torrance, California, 90502
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114
United States
Jack Weiler Hosp / Bronx Municipal Hosp
Bronx, New York, 10465
United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
United States
Duke Univ Med Ctr
Durham, North Carolina, 27710
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
United States
Univ Hosp of Cleveland / Case Western Reserve Univ
Cleveland, Ohio, 44106
United States
City Hosp Ctr at Elmhurst / Mount Sinai Hosp
Elmhurst, New York, 11373
United States
Cornell Univ Med Ctr
New York City, New York, 10021
United States
Columbus Children's Hosp
Columbus, Ohio, 432052696
United States
St Louis Regional Hosp / St Louis Regional Med Ctr
St. Louis, Missouri, 63112
United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
United States
Stanford at Kaiser / Kaiser Permanente Med Ctr
San Francisco, California, 94115
United States
Thomas Jefferson Univ Hosp
Philadelphia, Pennsylvania, 19107
United States
SUNY - Stony Brook
Stony Brook, New York, 117948153
United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228
United States
UCLA CARE Ctr
Los Angeles, California, 90095
United States
Holmes Hosp / Univ of Cincinnati Med Ctr
Cincinnati, Ohio, 452670405
United States
Stanford Univ School of Medicine
Stanford, California, 94305
United States
Montefiore Med Ctr / Bronx Municipal Hosp
Bronx, New York, 10467
United States
Palo Alto Veterans Adm Med Ctr / Stanford Univ
Palo Alto, California, 94304
United States
Beth Israel Deaconess - West Campus
Boston, Massachusetts, 02215
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
Saint Luke's - Roosevelt Hosp Ctr
New York City, New York, 10025
United States
Mount Sinai Med Ctr
New York City, New York, 10029
United States
Univ of Minnesota
Minneapolis, Minnesota, 55455
United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
Bronx, New York, 10461
United States
Univ of Pittsburgh Med School
Pittsburgh, Pennsylvania,
United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037
United States
Beth Israel Med Ctr / Peter Krueger Clinic
New York City, New York, 10003
United States
Additional Information:
Study ID Numbers: ACTG 016;
Study Start Date:
Record last reviewed: January 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001011
Other Hiv Infections Studies:
1. A Study to Compare Two Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Previously Received Anti-HIV Treatment
2. Intracellular Pharmacokinetics of Zidovudine Triphosphate in Maternal and Infant Cord Blood Mononuclear Cells.
3. A Phase I Safety and Immunogenicity Trial of UBI Microparticulate Monovalent HIV-1 MN Peptide Immunogen in HIV-1 Seronegative Human Subjects
4. A Phase I, Multicenter, Randomized, Double-Blind, Placebo-Controlled HIV-1 Vaccine Trial to Evaluate the Safety and Immunogenicity of MN Recombinant Soluble gp120/HIV-1 (rsgp120/HIV-1) (Genentech) in Combination With QS21 Adjuvant and/or Alum in Healthy Adults
5. The Safety and Effectiveness of Zidovudine in HIV-Infected Pregnant Women and Their Infants
Related Studies:
Other HIV Infections Clinical Trials
Other North Carolina Clinical Trials
Other Chapel Hill Clinical Trials
The Safety and Effectiveness of Zidovudine in the Treatment of Patients with Early AIDS Related Complex
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